Kornimate/medical-research-clean huggingface dataset:
vietnam cryptococcal retention in care study version 1.0

Conditions: Meningitis, Cryptococcal; Central Nervous System Fungal Infections; Central Nervous System Infections; Meningitis, Fungal

Summary: it is hypothesized that implementing plasma crag screening in clinics providing routine hiv care will enable identification of vietnamese adult patients with advanced hiv (cd4 ≤100 cells/μl) who have early cryptococcal disease, enable prompt preemptive treatment with high-dose fluconazole, and improve survival.

this is multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (crag) screening program in vietnam. hiv-infected patients with cd4 ≤100 cells/μl who present for hiv care at outpatient clinics (opcs) in vietnam where crag screening is offered will be recruited into the study. study participants will be screened for cryptococcal antigen using the lateral flow assay (lfa) and followed up for 12 months with clinical assessments and the collection of routine and supplemental survey data. those who are crag-positive, but have no features of central nervous system (cns) disease, will be treated with high-dose fluconazole. those with symptoms of cns disease will be treated according to national guidelines. survival, retention in care, and other clinical outcomes will be documented for patients who test crag-positive and are treated with fluconazole and those who test crag-negative.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * confirmed hiv infection using national testing algorithm * cd4 ≤100 cells/μl * able to provide written informed consent exclusion criteria: * history of prior cm * receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months * currently taking art or history of art for more than 4 weeks within the past year * known to be currently pregnant or planning to become pregnant during the study period

Keywords: cryptococcal meningitis hiv aids fluconazole
spanish adaptation and study of reliability of the european quality questionnaire (euroq2)

Conditions: Critical Illness

Summary: the aim of this study is to adapt and validate to the spanish the european quality questionnaire (euroq2) to evaluate families' experiences of quality of care for critically ill and dying patients in the icu.

the aim of this study is to adapt and validate a spanish-language version of the european quality questionnaire (euroq2). using a forward-backward translation methodology, we will translate the euroq2 into spanish and will evaluate its psychometric characteristics in a clinical sample of 200 family members responsible for making medical decisions for patients who are discharged from the icu or who died in the icu. cronbach's alpha values, confirmatory factor analysis (cfa) will be evaluated in order to know the reliability, construct validity, and convergent validity.

Eligibility criteria:
inclusion criteria: * family members of patients admitted to the icu for 48 hours or more. * family members responsible for patient decision making in the icu who consent participate. exclusion criteria: * family members younger than 18 years, * family members not able to read or write spanish

Keywords: family quality validate icu
treatment of osteonecrosis of the femoral head by bone marrow transplantation

Conditions: Necrosis

Summary: aseptic non traumatic osteonecrosis (on) is a painful disorder of the hip which often leads, in its final stage, to femoral head collapse and subsequent total hip replacement. core decompression of the hip is the most widespread procedure used to treat early stage on of the femoral head. notwithstanding the fact that this procedure has been employed for more than three decades (2), its efficacy remains controversial (3;4). recently, one suggested that on might be a disease of bone cells and/or of mesenchymal cells. the levels of activity and the number of mesenchymal stem cells in both the hematopoietic and in the stromal compartments of the bone marrow have been shown to be depressed in patients with on of the femoral head (9). the investigators have showed previously that the capacity of osteoblastic cells to replicate was decreased in the proximal femur of patients with on of the femoral head (10). this finding raised the possibility that bone marrow containing stromal cells which have many of the characteristics of stem cell for mesenchymal tissues including bone could be implanted into the necrotic lesion of the femoral head.


Eligibility criteria:
inclusion criteria: * arco stage 1 or 2 osteonecrosis of the femoral head exclusion criteria: * the investigators excluded patients with evidence of a malignant disorder during the past five years.

Keywords: osteonecrosis bone marrow core decompression femoral head
study of nivolumab in combination with ipilimumab compared to the standard of care (extreme regimen) as first line treatment in patients with recurrent or metastatic squamous cell carcinoma of the head and neck

Conditions: Head and Neck Cancer

Summary: the main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx \& larynx) that is not amenable to curative therapy. * no prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment). * measurable disease detected by imaging exam (ct or mri). * have tumor tissue for pd l1 expression testing, and for oropharyngeal cancer have results from testing of hpv p16 status. exclusion criteria: * metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma). * no prior treatment with anti pd1, anti pd l1, anti ctla 4 antibody or any other antibody or drugs targeting t cell costimulation or checkpoint pathways, or cetuximab or egfr inhibitors in any treatment setting. * participants with certain diseases such as active autoimmune disease, type i diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder. * inadequate hematologic, renal or hepatic function. other protocol defined inclusion/exclusion criteria could apply
an investigator-initiated study to assess the cooling effect of triamcinolone acetonide aerosol when used for steroid-responsive dermatoses

Conditions: Acute Steroid Responsive Dermatoses; Chronic Steroid Responsive Dermatoses

Summary: triamcinolone acetonide is a mid-potency, class 4/5 topical corticosteroid that is available in a spray formulation (triamcinolone acetonide spray, t spray). it is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. unlike more potent steroid products, t spray has no time limitations on its use; therefore, it is commonly used to treat flares in psoriasis, atopic dermatitis, seborrheic dermatitis, and contact dermatitis. in contrast to creams and ointments, t spray can easily cover large and hard-to-reach areas of the body. its optional nozzle directs application of the medication to precise areas without affecting nearby areas. patients requiring a mid-potency corticosteroid for lesions on the scalp, back, intertriginous folds, large areas, or areas that require precise application would benefit from the t spray formulation. in the time since the introduction of t spray to dermatology, other topical corticosteroids have entered the market, but t spray remains the only mid-potency corticosteroid available in a spray formulation. in a recently published open-label, non-comparator study involving 42 patients with chronic steroid-responsive dermatoses, t spray was used up to four times a day for 28 days. improvement of lesions after one week of treatment was experienced by 85% of patients, and 95% of subjects preferred the spray over creams and ointment. most importantly, 56% of patients reported an anti-pruritic cooling effect which was experienced upon application.


Eligibility criteria:
inclusion criteria: 1. subjects must be at least 18 years old and in good general health, as confirmed by a medical history 2. a clear diagnosis of the chronic steroid-responsive dermatosis (i.e. psoriasis, atopic dermatitis) or acute steroid-responsive dermatosis (i.e. contact dermatitis, first-degree burn) must have been previously established and patients must have a target lesion that can be assessed for severity of inflammation 3. females of childbearing potential must have a negative urine pregnancy test to participate in the study 4. subjects must be able to understand the requirements of the study and sign an informed consent prior to study procedures exclusion criteria: 1. subjects who are pregnant and/or nursing 2. subjects with a known hypersensitivity to any component of the t spray 3. subjects who are using any medication or have a disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study 4. subjects with any of the following pathologies: cold urticaria, cryoglobulinemia, raynaud's phenomena, or paroxysmal cold hemoglobulinuria
manual therapy in patients with asthma

Conditions: Asthma

Summary: physical therapists have traditionally included various forms of manual therapy among the therapeutic approaches to respiratory conditions. the aim of this study was to evaluate the effect of diaphragmatic stretching technique on pulmonary ventilation, rig bage excursion and spirometric values in patients diagnosed with asthma.

asthma is a chronic lung disease involving an inflammation and a narrowing of the airways. asthma causes wheezing, chest tightness, shortness of breath, and coughing. a variety of manual therapies are commonly used to treat patients with asthma. there is a need to conduct studies in order to examine the effects of manual therapies on clinically relevant outcomes. techniques aim to increase movement in the rib cage and the spine to try and improve the working of the lungs and circulation.

Eligibility criteria:
inclusion criteria: * age ranging between 18 and 45 years. * diagnosis of asthma. * no exacerbations during last month. exclusion criteria: * history of spine surgery. * diabetes, neurological or a cardiovascular disease. * spine deformities and use of orthopedic devices.

Keywords: stretching, diaphragm, asthma, manual therapy
validation of the chinese version of oxford depression questionnaire

Conditions: Mood Disorders; Emotional Blunting

Summary: mood disorders are a group of psychiatric disorders that can affect a person's mood, energy, and motivation. emotional blunting has been observed in clinical practice in patients with mood disorders. emotional blunting has a negative impact on patients' overall treatment and leads to poorer adherence. the oxford depression questionnaire (odq) is a measuring instrument of emotional blunting. the odq is expected to be a scientifically valid tool for detecting emotional blunting. the odq has high construct validity and internal reliability. however, no scientific validity studies have been conducted on odq in chinese population. therefore, this study is intended to investigate the reliability and validity of the odq in chinese patients with mood disorders.


Eligibility criteria:
inclusion criteria: 1) both biological parents were han chinese; 2) currently diagnosed with major depressive disorder or bipolar disorder according to the mini international neuropsychiatric interview for diagnostic and statistical manual of mental disorders, fifth edition; 3) aged 13-65 years; 4) can complete the self-assessment questionnaires. exclusion criteria: 1) currently diagnosed with neurological diseases or other major psychiatric disorders, e.g., schizophrenia, cognitive impairment, substance abuse; 2) diagnosed with severe somatic illnesses, such as diabetes and cardiovascular diseases;
effect of mojzisova method on pain, menstrual symptom and insomnia in pd

Conditions: Primary Dysmenorrhea

Summary: this project was a randomized controlled trial conducted to check the effectiveness of mojzisova method in primary dysmenorrhea for pain, menstrual symptoms and insomnia. duration was of 6 months, convenient sampling was done, subject following eligibility criteria from dhq hospital toba tek were randomly assigned, baseline assessment was done, group a paarticipants were given baseline treatment along with mojzisova method, group b participants were given baseline treatment along with stretching exercises, post intervention assessment was done, via walidd, numeric pain rating scale (nprs) and pittsburgh sleep quality index (psqi) questionnaire 45 minutes per session, 2 sessions per month for 3 months, data was analyzed by using spss version 26.

primary dysmenorrhea is most common reported problems to gynecologists and physical therapists. there is long history of using over the counter painkillers. due to this there is high absenteeism from schools colleges and work. on the basis of symptoms primary dysmnorhea can be separated from secondary dysmenorrhea.physical activity has long been used for relieving the pain, menstrual symptoms and improve insomnia. previous studies also reported the effects of stretching exercises, core stabilizing exercises yoga, pilates, aerobics on improving the pain and symptoms in primary dysmenorrhea. according to researcher knowledge there is limited evidence on mojzisova method that how this method improve the menstrual symptoms, pain and insomnia in primary dysmenorrhea. the aim of this study is to see the effects of mojzisova method on pain, menstrual symptom and insomnia in primary dysmenorrhea.

Eligibility criteria:
inclusion criteria: * pain must be recurrent (at least following three menstrual cycles). * no history of any blood problems, such as thalassemia, folate insufficiency, or anemia due to a lack of iron. five criteria to fulfill to be considered primary dysmenorrhea. * hypogastrium pain during menstruation. * irradiation of pain to lower back, lower limbs or lingual region. * inability to perform daily activity. * the need for medical management or self-medication to control pain nulliparous women with primary dysmenorrhea. exclusion criteria: * female with history of any specific disease. * female with endocrine disorders. * had gone major surgery. * diagnosis of secondary dysmenorrhea. * having symptoms such as numbness and tingling sensation.

Keywords: insomnia menstrual symptom pain primary dysmenorrhea stretching
activity and metformin intervention in obese adolescents

Conditions: Obesity; Type 2 Diabetes

Summary: the purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (bmi) and metabolic and vascular health in obese youth. the study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. an initial intensive exercise program will also be compared with a standard exercise program. hypothesis: metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved bmi, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function.

this study will assess the sustainability of a two-year intervention and the degree of improvement in body mass index (bmi) and reduction in risk factors for type 2 diabetes and diabetes related cardiovascular disease, as well as evaluating the additive effect of metformin (as glumetzatm 500 mg extended release tablets) and comparing an initial intensive exercise program with a standard exercise program. the study will recruit obese youth who are at risk for type 2 diabetes and cardiovascular disease.

Eligibility criteria:
inclusion criteria: * obese adolescents defined as bmi greater than the 95th percentile for age and gender * metformin naive subjects exclusion criteria: * elevated fasting plasma glucose ≥ 6.0 mmol/l * 2 hour plasma glucose ≥ 11.1 mmol/l after a standard glucose load * a1c \> 6.0% * medication other than "over the counter" drugs, oral contraceptive pill or thyroid hormone replacement * smoking * pregnancy * renal insufficiency (serum creatinine \> the upper limit of normal) * hepatic dysfunction (\> 1.5 times the upper limit of normal for ast and alt) * latex allergy * hypersensitivity to metformin or its ingredients * breast feeding * subjects with a history of lactic acidosis * abnormal creatinine clearance * hiv, hbv, and hcv infections * drug and alcohol abuse * severe mental disorders * subjects who are planning radiologic exams involving in i.v. injection of iodinated contract materials * participation in another clinical trial * significant history or presence of cardiovascular, pulmonary, gastrointestinal, immunologic, endocrine, neurologic disorders * malignant diseases * previous exposure to any pharmaceutical antidiabetic agent

Keywords: obesity metformin physical activity cardiovascular health
intracranial pressure (icp) monitoring following traumatic brain injury (tbi)

Conditions: Traumatic Brain Injury

Summary: the aim of this retrospective cohort study is to evaluate complications rates, indications, and the utility of follow-up imaging studies of icp measurement in severe tbi patients.


Eligibility criteria:
inclusion criteria: * severe traumatic brain injury (gcs\<9 on arrival) * implantation of invasive intracranial parenchymal icp monitoring exclusion criteria: * incomplete data records

Keywords: intracranial pressure monitoring
the impact of sleep disorders on motor vehicle accidents

Conditions: Sleep Disorders

Summary: patients who have sleep disorders may be involved in accidents more frequently than those without. in addition patients who have sleep disorders may have more serious accidents and have increased length of stay.we aim to recruit drivers admitted as a result of a motor vehicle accidents and to ascertain the prevalence of sleep disorders in this group.


Eligibility criteria:
inclusion criteria:drivers admitted as result of motor vehicle accidents - exclusion criteria:drivers aged \< 18 years -
comparing the prepex™ device to surgical mc for rapid scale up of mc in resource limited setting

Conditions: HIV

Summary: the protocol, approved by the medical research council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in zimbabwe

models show that to have the highest impact on the hiv epidemic, circumcision of up to 80% of men in high prevalence countries, where mc rates are low, needs to be achieved (unaids 2009; manicaland hiv/std prevention project, 2008; bollinger, et al, 2009). hallett and colleagues in 2008 showed that for zimbabwe specifically, hiv incidence could be reduced between 25% to 35% if about 50% of men are circumcised. all modelings conducted show that mc programs must be part of a comprehensive hiv prevention package as mc alone will not tip the hiv epidemic into a terminal decline. the prepex device offers hope for rapid scale up of adult male circumcision in resource limited settings. once the safety and efficacy have been established, it is important to conduct operations research to determine how best to implement both device and surgical circumcisions in the national program. thus, the zimbabwe mohcw is planning a three phase trial in order to determine the safety of the prepextm device, its performance and the ease of use in an implementation roll out.

Eligibility criteria:
inclusion criteria: * ages 18 - 30 years * uncircumcised * wants to be circumcised * agrees to be circumcised by any of the study methods,prepextm or surgical as appropriate * hiv sero-negative * able to understand the study procedures and requirements * agrees to abstain from sexual intercourse and to keep caution not to directly rub the cut area if masturbating, for 8 weeks post removal (9 weeks total) * agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total) * subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study * subject agrees to anonymous video and photographs of the procedure and follow up visits * agrees to stay overnight at the hospital in order to follow pain measurements in the first 16 hours exclusion criteria: * active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision * hiv sero-positive * subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias * known bleeding / coagulation abnormality * uncontrolled diabetes * subject that to the opinion of the investigator is not a good candidate * subject does not agree to anonymous video and photographs of the procedure and follow up visits * refusal to take hiv test.

Keywords: male circumcision hiv prevention medical device
comparison of human insulin produced by the current process and the nn729 process in healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product actrapid®.


Eligibility criteria:
inclusion criteria: * normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant * fasting blood glucose below or equal to 6 mmol/l * body mass index (bmi) 22.0-27.0 kg/m\^2 (both inclusive) exclusion criteria: * participated in another clinical study with an investigational drug within the last 4 weeks * any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. occasional paracetamol is acceptable * known or suspected allergy to the trial product or related products * family history of type 1 diabetes